Vertex also announced enrollment completion of the IA cohort of AMPLITUDE, a global Phase 2/3 clinical trial designed to assess the impact of inaxaplin on kidney function and proteinuria for people living with AMKD. Inaxaplin is an investigational small molecule inhibitor of APOL1 aimed at addressing the underlying cause of AMKD. The AMPLITUDE study is designed with an interim analysis at Week 48 in a pre-specified number of patients to assess percent change from baseline in proteinuria and eGFR slope in the inaxaplin arm versus placebo. If positive, the IA will serve as the basis for Vertex to seek accelerated approval of inaxaplin in the U.S.
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